Spots Global Cancer Trial Database for Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma
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Trial Identification
Brief Title: Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma
Official Title: Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma
Study ID: NCT00245141
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma.
Detailed Description: OBJECTIVES: * Determine the progression-free survival rate in patients with low-risk embryonal rhadomyosarcoma treated with a shortened treatment schedule of vincristine, dactinomycin, and cyclophosphamide with or without radiotherapy. OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV. Patients may also undergo radiotherapy. Treatment repeats every 3 weeks for up to 8 courses (total of 24 weeks) in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Eligibility
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Anjo Kosei Hosptial, Anjo, Aichi, Japan
Aichi Medical University, Nagakuti, Aichi, Japan
National Hospital Orgnization Nagoya Medical Center, Nagoya, Aichi, Japan
Ehime Prefectural Central Hospital, Matsuyama-shi, Ehime, Japan
National Kyushu Cancer Center, Fukuoka-shi, Fukuoka, Japan
Kurume University School of Medicine, Kurume City, Fukuoka, Japan
Gifu Municipal Hospital, Gifu-shi, Gifu, Japan
Gunma Children's Medical Center, Seta-gun, Gunma, Japan
National Hospital Organization - Medical Center of Kure, Kure, Hiroshima, Japan
Sapporo Medical University, Sapporo, Hokkaido, Japan
Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan
Kobe City General Hospital, Kobe, Hyogo, Japan
Ibaraki Children's Hospital, Mito-shi, Ibaraki, Japan
University of Tsukuba, Tsukuba-city, Ibaraki, Japan
Ishikawa Prefectural Central Hospital, Kanazawa-shi, Ishikawa, Japan
Kanazawa Medical University, Kanazawa, Ishikawa, Japan
Kagoshima City Hospital, Kagoshima City, Kagoshima, Japan
National Center for Child Health and Development, Tokyo, Kanagawa, Japan
Showa University Fujigaoka Hospital, Yokohama-shi, Kanagawa, Japan
Yokohama City University, Yokohama, Kanagawa, Japan
Miyazaki Medical College University of Miyazaki, Miyazaki-gun, Miyazaki, Japan
Nagano Children's Hospital, Toyoshina-machi, Nagano, Japan
Osaka Medical Center and Research Institute for Maternal and Child Health, Izumi, Osaka, Japan
Osaka City General Hospital, Suita-shi, Osaka, Japan
Osaka University Graduate School of Medicine, Suita-shi, Osaka, Japan
Osaka Medical College, Takatsuki City, Osaka, Japan
Dokkyo University School of Medicine, Koshigaya, Saitama, Japan
National Defense Medical College, Tokorozawa, Saitama, Japan
Shiga University of Medical Science, Otsu-shi, Shiga, Japan
Shimane Prefectural Central Hospital, Izumo, Shimane, Japan
Shimane University Hospital, Izumo, Shimane, Japan
Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan
Tokyo Metropolitan Kiyose Children's Hospital, Kiyosei, Tokyo, Japan
Fukushima Medical University Hospital, Fukushima, , Japan
Gifu University Graduate School of Medicine, Gifu, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Kagoshima University, Kagoshima, , Japan
Kyoto Prefectural University of Medicine, Kyoto, , Japan
Kyoto University Hospital, Kyoto, , Japan
Osaka City University, Osaka, , Japan
Osaka General Medical Center, Osaka, , Japan
Saitama Children's Medical Center, Saitama, , Japan
Hokkaido Medical Center for Child Health and Rehabilitation, Sapporo, , Japan
National Cancer Center Hospital, Tokyo, , Japan
St. Luke's International Hospital, Tokyo, , Japan
Tokyo Medical and Dental University, Tokyo, , Japan
Toho University School of Medicine, Tokyo, , Japan
Keio University School of Medicine, Tokyo, , Japan
Nihon University Itabashi Hospital, Tokyo, , Japan
Toyama University Hospital, Toyama, , Japan
Yamagata University Hospital, Yamagata, , Japan
Contact Details
Name: Hajime Hosoi
Affiliation: Kyoto Prefectural University of Medicine
Role: STUDY_CHAIR
Name: Masa-aki Kumagai, MD
Affiliation: National Center for Child Health and Development
Role:
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